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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The customer contacted physio-control to report that their device boots up a completely blank display.A blank display can be indicative of a device lock-up condition.As a result, defibrillation therapy may not be available, if it is needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue of the device having a blank display, however physio confirmed the device was still able to power on and perform its critical functions.Physio replaced the device's backlight inverter to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the device's removed backlight inverter and determined that the cause of the reported issue was due to damage to a transformer, designator t2.The damage caused t2 to be electrically open and the device to have a blank display.
 
Event Description
The customer contacted physio-control to report that their device boots up a completely blank display.A blank display can be indicative of a device lock-up condition.As a result, defibrillation therapy may not be available, if it is needed.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK® 20 DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7619655
MDR Text Key111686857
Report Number0003015876-2018-00967
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Date Manufacturer Received08/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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